BEUDAMED
    FDA Adverse Event Death Summary report: N

    PALMAZ STENT UNKNOWN

    MDR report key: 2446969 · Received February 13, 2012

    Report

    Report Number
    9616099-2012-00079
    Event Type
    Death
    Date Received
    February 13, 2012
    Date of Event
    March 9, 2007
    Report Date
    February 2, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (15,200/MM2), ANEMIA (10.2 G/DL), AND ELEVATED C-REACTIVE PROTEIN (19.5 MG/DL). THE PATIENT UNDERWENT AN EMERGENCY OPERATION. RATHER THAN PERCUTANEOUS STENT-GRAFT REPAIR, WE SELECTED OPEN SURGICAL RECONSTRUCTION OF THE EXTRA-ANATOMICAL BYPASS DUE TO THE SEVERE INFECTION. A MIDLINE ABDOMINAL INCISION WAS MADE, AND THE PSEUDOANEURYSM OF THE EIA WAS STRONGLY ADHERENT TO THE SIGMOID COLON. THE PSEUDOANEURYSM OF THE EIA WAS OPENED TO REVEAL A FRACTURED SECOND PALMAZ STENT THAT HAD PERFORATED THE SIGMOID COLON. WE RESECTED THE PSEUDOANEURYSM, WIDELY DEBRIDED THE INFECTED TISSUES, AND CLOSED THE WOUND. WE THEN STERILIZED THE GROIN THOROUGHLY AND PERFORMED A FEMOROFEMORAL BYPASS WITH AN EXPANDED POLYTETRAFLUOROETHYLENE (EPTFE) GRAFT. WE COVERED THE EIA STUMP WITH AN OMENTUM FLAP. (B)(6) WAS DETECTED IN CULTURES OF BLOOD, SPUTUM, AND AN OPERATIVE SPECIMEN. UNFORTUNATELY, THE PATIENT DIED FROM SEPTIC SHOCK 25 DAYS AFTER THE SURGERY. PLEASE NOTE THAT THE EXACT DATE OF THE EVENT IS NOT KNOWN BUT THE DATE OF PUBLICATION IS BEING USED INSTEAD AS THE EVENT DATE AS PER THE MEDICAL DEVICE REPORTING GUIDELINES. PLEASE NOTE: THE CATALOG CODE ENTERED (PXXXXX), REPRESENTS AN UNKNOWN PALMAZ STENT. THE CATALOG AND LOT NUMBERS FOR THE ACTUAL PRODUCT USED IN THE PROCEDURE ARE UNKNOWN AND ARE NOT AVAILABLE. KONDO ET AL IN LATE INFECTED PSEUDOANEURYSM FORMATION AFTER UNEVENTFUL ILIAC ARTERY STENT PLACEMENT; ANN VASC SURG 2007; 21: 222-224, DOI: 10.1016/J.AVSG.2006.06.00; PRESENT A CASE OF RUPTURE OF AN INFECTED PSEUDOANEURYSM AT THE SITE OF THE EXTERNAL ILIAC ARTERY THAT OCCURRED 4 MONTHS AFTER AN UNEVENTFUL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND STENT PLACEMENT OF 3 PALMAZ STENTS. DURING SURGICAL RECONSTRUCTION (DUE TO THE SEVERE INFECTION), THE PSEUDOANEURYSM OF THE EIA WAS OPENED TO REVEAL A FRACTURED SECOND PALMAZ STENT THAT HAD PERFORATED THE SIGMOID COLON. THE PATIENT SUBSEQUENTLY DIED DUE TO SEPTIC SHOCK. IN ADDITION, DURING THE INITIAL PROCEDURE IN WHICH TWO PALMAZ STENTS WERE DEPLOYED, A THIRD PALMAZ STENT WAS DEPLOYED DUE TO PLAQUE SHIFT. A (B)(6) MAN WITH INCREASING REST PAIN IN THE LEFT LEG WAS REFERRED TO OUR DEPARTMENT. HIS PAST HISTORY INCLUDED DIABETES MELLITUS AND HYPERTENSION. HE WAS DIAGNOSED WITH A 99% STENOSIS OF THE LEFT EIA BY DIGITAL SUBTRACTION ARTERIOGRAPHY. HE UNDERWENT SUCCESSFUL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND STENT PLACEMENT WITH THREE PALMAZ STENTS. TWO PALMAZ STENTS WERE DEPLOYED ACROSS THE STENOSES AND DILATED TO 8 MM, AND ANOTHER PALMAZ STENT WAS DEPLOYED DISTALLY BECAUSE OF THE PLAQUE SHIFT. WE ADMINISTRATED PROPHYLACTIC ANTIBIOTIC THERAPY PERIOPERATIVELY, AND HE WAS DISCHARGED UNEVENTFULLY. APPROXIMATELY 4 MONTHS LATER HE PRESENTED TO A LOCAL HOSPITAL WITH HIGH FEVER, MELENA, LEFT LEG SWELLING, AND LEFT LOWER ABDOMINAL PAIN. HE WAS DIAGNOSED WITH GASTROINTESTINAL BLEEDING, PNEUMONIA, AND PSEUDOANEURYSM AND TREATED WITH BLOOD TRANSFUSION AND ANTIBIOTICS. HE PRESENTED MELENA SEVERAL TIMES IN THE HOSPITAL, AND HIS GENERAL CONDITION DETERIORATED. FIVE DAYS LATER HE WAS TRANSFERRED TO OUR HOSPITAL. COMPUTED TOMOGRAPHY SHOWED A PSEUDOANEURYSM AT THE SITE OF STENT PLACEMENT. A LABORATORY ANALYSIS SHOWED ELEVATED WHITE CELL COUNT. (15,200/MM2), ANEMIA (10.2 G/DL), AND ELEVATED C-REACTIVE PROTEIN (19.5 MG/DL). THE PATIENT UNDERWENT AN EMERGENCY OPERATION. RATHER THAN PERCUTANEOUS STENT-GRAFT REPAIR, WE SELECTED OPEN SURGICAL RECONSTRUCTION OF THE EXTRA-ANATOMICAL BYPASS DUE TO THE SEVERE INFECTION. A MIDLINE ABDOMINAL INCISION WAS MADE, AND THE PSEUDOANEURYSM OF THE EIA WAS STRONGLY ADHERENT TO THE SIGMOID COLON. THE PSEUDOANEURYSM OF THE EIA WAS OPENED TO REVEAL A FRACTURED SECOND PALMAZ STENT THAT HAD PERFORATED THE SIGMOID COLON. WE RESECTED THE PSEUDOANEURYSM, WIDELY DEBRIDED THE INFECTED TISSUES, AND CLOSED THE WOUND. WE THEN STERILIZED THE GROIN THOROUGHLY AND PERFORMED A FEMOROFEMORAL BYPASS WITH AN EXPANDED POLYTETRAFLUOROETHYLENE (EPTFE) GRAFT. WE COVERED THE EIA STUMP WITH AN OMENTUM FLAP. (B)(6) WAS DETECTED IN CULTURES OF BLOOD, SPUTUM, AND AN OPERATIVE SPECIMEN. UNFORTUNATELY, THE PATIENT DIED FROM SEPTIC SHOCK 25 DAYS AFTER THE SURGERY. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. STENT FRACTURES ARE WELL-KNOWN POTENTIAL COMPLICATIONS OF THIS TYPE OF PROCEDURE AND ARE LISTED IN THE IFU AS SUCH. FRACTURE OF SELF-EXPANDING STENTS PLACED IN THE ILIAC ARTERY OCCURS IN APPROXIMATELY 5% OF THE CASES. STENTING IN CHRONIC OCCLUSION REPRESENTS AN INCREASED RISK FACTOR FOR FRACTURE. FRACTURES OF STENTS PLACED IN ILIAC ARTERIES RARELY AFFECT PATENCY. SEVERAL MITIGATING FACTORS FOR THESE FRACTURES HAVE BEEN PROPOSED INCLUDING REPEATED STRESS AND TORSION OF THE ARTERY, CALCIFIED PLAQUES, STRESS PRODUCED BY MULTIPLE, OVERLAPPING STENTS, AND CONVERSION OF MICROFRACTURES RELATED TO STENT MANUFACTURING. THE ILIAC VESSELS ARE PRONE TO AND UNDERGO BIOMECHANICAL FORCES SUCH AS FLEXION DURING MOVEMENT. ILIAC ARTERY CONFORMATION, PARTICULARLY EXTERNAL ILIAC ARTERY (EIA), IS CHANGED BY BENDING OF THE HIP JOINT, SO STENTS PLACED IN ILIAC ARTERIES COULD BE MECHANICALLY STRESSED. SEVERAL MECHANISMS MUST BE CONSIDERED FOR STENT FRACTURE IN THE ILIAC ARTERY. IT HAS BEEN REPORTED THAT THE ILIAC ARTERY, PARTICULARLY EIA, IS EXPOSED TO FLEXION BY BENDING THE HIP JOINT, WHICH SEEMS LIKELY TO BE ASSOCIATED WITH STENT FRACTURE IN ILIAC ARTERIES. IN THIS STUDY, STENT FRACTURE WAS DETECTED IN CIA AS WELL AS EIA. FRACTURE OF STENT PLACED IN CIA MIGHT BE AFFECTED BY THE COMPLEX MOTION INTRODUCED BY THE SPINE IN ADDITION TO THE HIP MOVEMENTS. ANOTHER CAUSE OF STENT FRACTURE MAY BE INTERNAL STRESS ON THE STRUCTURE. A SIGNIFICANT AMOUNT OF INTERNAL STRESS IS CONSIDERED TO BE TRANSMITTED TO THE STENT MATERIAL AS A RESULT OF PULSATILE FLOW. THIS PHENOMENON IS DESCRIBED AS HIGHER IN STENTS PLACED IN THE PULMONARY ARTERY OR AORTA. HOWEVER, WHETHER THE ILIAC ARTERY CAN BE AFFECTED BY PULSATILE BLOOD FLOW AS IN GREAT VESSELS HAS NOT BEEN ESTABLISHED. A PSEUDOANEURYSM IS A TYPE OF "BUBBLE" ON THE ARTERY DUE TO A PENETRATING INJURY TO THE ARTERY. AN OPENING IN THE ARTERY LEADS TO LEAKAGE OF BLOOD FROM THE FEMORAL ARTERY ( A "HEMATOMA"). THIS HEMATOMA DEVELOPS A WALL AROUND IT AND THE HEMATOMA LIQUEFIES AND FORMS A PULSATING "BUBBLE" ON THE ARTERY. THIS IS CALLED A PSEUDOANEURYSM. A PSEUDOANEURYSM, LIKE ANY ANEURYSM, CAN RUPTURE AND CAUSE BLEEDING OR LOSS OF LIMB. A PSEUDOANEURYSM CAN DEVELOP ON THE ILIAC ARTERY DUE TO ANY PENETRATING INJURY OF THE ARTERY. THE MOST COMMON PENETRATING "INJURY" OF THE ILIAC ARTERY OCCURS DURING CARDIAC CATHETERIZATION PERFORMED VIA THE FEMORAL ARTERY. COMPLICATIONS REPORTEDLY OCCUR IN 9.9% OF ILIAC ARTERY STENT PLACEMENTS AND INCLUDE FAILURE OF STENT EXPANSION, IMPROPER STENT LOCATION, THROMBOSIS, DISSECTION, DISTAL EMBOLI, AND HEMATOMA OR PSEUDOANEURYSM FORMATION AT THE PUNCTURE SITE. CASES OF INFECTED PSEUDOANEURYSM FORMATION ARE VERY RARE AFTER STENT PLACEMENT AND THE OCCURRENCE OF AN ANEURYSM IS UNPREDICTABLE. MOST CASES REPORTEDLY OCCUR EARLY (<2 WEEKS) AFTER STENT PLACEMENT, SUGGESTING A FAILURE IN STERILE TECHNIQUE AS THE LEADING CAUSATIVE FACTOR. CAUSES OF PSEUDOANEURYSM FORMATION REPORTEDLY INCLUDE FRACTURE OF THE STENT, DISSECTION OF THE VESSELS, WALL INSTABILITY, AND INFECTION OF THE STENT. THE PERIPHERAL EMBOLISM LIKELY OCCURRED AS A RESULT OF A PLAQUE SHIFT DURING STENT DEPLOYMENT AS NOTED IN THE ARTICLE. THIS IS A WELL-KNOWN POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE AND IS LISTED IN THE IFU AS SUCH. THIS IS ONE OF THREE DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURING NUMBERS 9616099-2012-00079, 9616099-2012-00080 AND 9616099-2012-00081.

    Description of Event or Problem · 1

    KONDO ET AL IN LATE INFECTED PSEUDOANEURYSM FORMATION AFTER UNEVENTFUL ILIAC ARTERY STENT PLACEMENT; ANN VASC SURG 2007; 21: 222-224, DOI: 10.1016/J.AVSG.2006.06.00; PRESENT A CASE OF RUPTURE OF AN INFECTED PSEUDOANEURYSM AT THE SITE OF THE EXTERNAL ILIAC ARTERY THAT OCCURRED 4 MONTHS AFTER AN UNEVENTFUL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND STENT PLACEMENT OF 3 PALMAZ STENTS. DURING SURGICAL RECONSTRUCTION (DUE TO THE SEVERE INFECTION), THE PSEUDOANEURYSM OF THE EIA WAS OPENED TO REVEAL A FRACTURED SECOND PALMAZ STENT THAT HAD PERFORATED THE SIGMOID COLON. THE PATIENT SUBSEQUENTLY DIED DUE TO SEPTIC SHOCK. IN ADDITION, DURING THE INITIAL PROCEDURE IN WHICH TWO PALMAZ STENTS WERE DEPLOYED, A THIRD PALMAZ STENT WAS DEPLOYED DUE TO PLAQUE SHIFT. A (B)(6) MAN WITH INCREASING REST PAIN IN THE LEFT LEG WAS REFERRED TO OUR DEPARTMENT. HIS PAST HISTORY INCLUDED DIABETES MELLITUS AND HYPERTENSION. HE WAS DIAGNOSED WITH A 99% STENOSIS OF THE LEFT EIA BY DIGITAL SUBTRACTION ARTERIOGRAPHY. HE UNDERWENT SUCCESSFUL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND STENT PLACEMENT WITH THREE PALMAZ STENTS (JOHNSON & JOHNSON INTERVENTIONAL SYSTEMS (B)(4)). TWO PALMAZ STENTS WERE DEPLOYED ACROSS THE STENOSES AND DILATED TO 8 MM, AND ANOTHER PALMAZ STENT WAS DEPLOYED DISTALLY BECAUSE OF THE PLAQUE SHIFT. WE ADMINISTRATED PROPHYLACTIC ANTIBIOTIC THERAPY PERIOPERATIVELY, AND HE WAS DISCHARGED UNEVENTFULLY. APPROXIMATELY 4 MONTHS LATER, HE PRESENTED TO A LOCAL HOSPITAL WITH HIGH FEVER, MELENA, LEFT LEG SWELLING, AND LEFT LOWER ABDOMINAL PAIN. HE WAS DIAGNOSED WITH GASTROINTESTINAL BLEEDING, PNEUMONIA, AND PSEUDOANEURYSM AND TREATED WITH BLOOD TRANSFUSION AND ANTIBIOTICS. HE PRESENTED MELENA SEVERAL TIMES IN THE HOSPITAL, AND HIS GENERAL CONDITION DETERIORATED. FIVE DAYS LATER, HE WAS TRANSFERRED TO OUR HOSPITAL. COMPUTED TOMOGRAPHY SHOWED A PSEUDOANEURYSM AT THE SITE OF STENT PLACEMENT. A LABORATORY ANALYSIS SHOWED ELEVATED WHITE CELL COUNT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ STENT UNKNOWN ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death| H| R